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Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use

BACKGROUND: The introduction of new technologies in endoscopy has been met with uncertainty, skepticism, and lack of standardization or training parameters, particularly when disruptive devices or techniques are involved. The widespread availability of a novel endoscopic suturing device (OverStitch™...

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Autores principales: Maranki, Jennifer L., Schwaitzberg, Steven D., Sharaiha, Reem Z., Kushnir, Vladimir M., Badurdeen, Dilhana S., Kumbhari, Vivek, Gómez, Victoria, Kumta, Nikhil A., Waye, Jerome D., Nieto, Jose, Ujiki, Michael B., Benias, Petros C., Miller, Larry S., Kedia, Prashant, Tarnasky, Paul, Mathew, Abraham, Levenick, John M., Inamdar, Sumant, Tharian, Benjamin, Nersesova, Yanina, Fredell, Lydia, Serra, Sonya, Kochman, Michael L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9362130/
https://www.ncbi.nlm.nih.gov/pubmed/35920904
http://dx.doi.org/10.1007/s00464-022-09392-7
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author Maranki, Jennifer L.
Schwaitzberg, Steven D.
Sharaiha, Reem Z.
Kushnir, Vladimir M.
Badurdeen, Dilhana S.
Kumbhari, Vivek
Gómez, Victoria
Kumta, Nikhil A.
Waye, Jerome D.
Nieto, Jose
Ujiki, Michael B.
Benias, Petros C.
Miller, Larry S.
Kedia, Prashant
Tarnasky, Paul
Mathew, Abraham
Levenick, John M.
Inamdar, Sumant
Tharian, Benjamin
Nersesova, Yanina
Fredell, Lydia
Serra, Sonya
Kochman, Michael L.
author_facet Maranki, Jennifer L.
Schwaitzberg, Steven D.
Sharaiha, Reem Z.
Kushnir, Vladimir M.
Badurdeen, Dilhana S.
Kumbhari, Vivek
Gómez, Victoria
Kumta, Nikhil A.
Waye, Jerome D.
Nieto, Jose
Ujiki, Michael B.
Benias, Petros C.
Miller, Larry S.
Kedia, Prashant
Tarnasky, Paul
Mathew, Abraham
Levenick, John M.
Inamdar, Sumant
Tharian, Benjamin
Nersesova, Yanina
Fredell, Lydia
Serra, Sonya
Kochman, Michael L.
author_sort Maranki, Jennifer L.
collection PubMed
description BACKGROUND: The introduction of new technologies in endoscopy has been met with uncertainty, skepticism, and lack of standardization or training parameters, particularly when disruptive devices or techniques are involved. The widespread availability of a novel endoscopic suturing device (OverStitch™) for tissue apposition has enabled the development of applications of endoscopic suturing. METHODS: The American Gastroenterological Association partnered with Apollo Endosurgery to develop a registry to capture in a pragmatic non-randomized study the safety, effectiveness, and durability of endoscopic suturing in approximating tissue in the setting of bariatric revision and fixation of endoprosthetic devices. RESULTS: We highlight the challenges of the adoption of novel techniques by examining the process of developing and executing this multicenter registry to assess real-world use of this endoscopic suturing device. We also present our preliminary data on the safety and effectiveness of the novel device as it is applied in the treatment of obesity. CONCLUSIONS: The Prospective Registry for Trans-Orifice Endoscopic Suturing Applications (ES Registry) was an effective Phase 4, postmarketing registry aimed at capturing pragmatic, real-world use of a novel device. These findings serve to solidify the role of endoscopic suturing in clinical practice.
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spelling pubmed-93621302022-08-10 Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use Maranki, Jennifer L. Schwaitzberg, Steven D. Sharaiha, Reem Z. Kushnir, Vladimir M. Badurdeen, Dilhana S. Kumbhari, Vivek Gómez, Victoria Kumta, Nikhil A. Waye, Jerome D. Nieto, Jose Ujiki, Michael B. Benias, Petros C. Miller, Larry S. Kedia, Prashant Tarnasky, Paul Mathew, Abraham Levenick, John M. Inamdar, Sumant Tharian, Benjamin Nersesova, Yanina Fredell, Lydia Serra, Sonya Kochman, Michael L. Surg Endosc Article BACKGROUND: The introduction of new technologies in endoscopy has been met with uncertainty, skepticism, and lack of standardization or training parameters, particularly when disruptive devices or techniques are involved. The widespread availability of a novel endoscopic suturing device (OverStitch™) for tissue apposition has enabled the development of applications of endoscopic suturing. METHODS: The American Gastroenterological Association partnered with Apollo Endosurgery to develop a registry to capture in a pragmatic non-randomized study the safety, effectiveness, and durability of endoscopic suturing in approximating tissue in the setting of bariatric revision and fixation of endoprosthetic devices. RESULTS: We highlight the challenges of the adoption of novel techniques by examining the process of developing and executing this multicenter registry to assess real-world use of this endoscopic suturing device. We also present our preliminary data on the safety and effectiveness of the novel device as it is applied in the treatment of obesity. CONCLUSIONS: The Prospective Registry for Trans-Orifice Endoscopic Suturing Applications (ES Registry) was an effective Phase 4, postmarketing registry aimed at capturing pragmatic, real-world use of a novel device. These findings serve to solidify the role of endoscopic suturing in clinical practice. Springer US 2022-08-03 2022 /pmc/articles/PMC9362130/ /pubmed/35920904 http://dx.doi.org/10.1007/s00464-022-09392-7 Text en © The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2022 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Article
Maranki, Jennifer L.
Schwaitzberg, Steven D.
Sharaiha, Reem Z.
Kushnir, Vladimir M.
Badurdeen, Dilhana S.
Kumbhari, Vivek
Gómez, Victoria
Kumta, Nikhil A.
Waye, Jerome D.
Nieto, Jose
Ujiki, Michael B.
Benias, Petros C.
Miller, Larry S.
Kedia, Prashant
Tarnasky, Paul
Mathew, Abraham
Levenick, John M.
Inamdar, Sumant
Tharian, Benjamin
Nersesova, Yanina
Fredell, Lydia
Serra, Sonya
Kochman, Michael L.
Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use
title Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use
title_full Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use
title_fullStr Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use
title_full_unstemmed Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use
title_short Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use
title_sort challenges of developing and executing a multi-site registry for a novel device with evolving indications for use
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9362130/
https://www.ncbi.nlm.nih.gov/pubmed/35920904
http://dx.doi.org/10.1007/s00464-022-09392-7
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